510(k) clearances

Premarket notifications cleared by FDA, newest decision first.

Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.

Data as of 2026-10-19, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.

Show the numbers

510(k) clearances by decision year, the last 15 years of ingested records
Year	Clearances
2012	3,135
2013	3,052
2014	3,202
2015	3,020
2016	2,956
2017	3,200
2018	3,062
2019	2,918
2020	2,923
2021	3,023
2022	3,209
2023	3,346
2024	3,129
2025	3,225
2026	2,618

176,415 records, page 480 of 3529

510(k) clearances, page 480 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K181782	Medline Reinforced Epidural Catheter	MEDLINE INDUSTRIES, LP - Northfield	BSO	Class II	2019-03-04
K182495	Electronic Blood Pressure Monitor	Shenzhen Jumper Medical Equipment Co.,Ltd.	DXN	Class II	2019-03-03
K190234	ODI HD Dental Sensor	Cnd Global Technologies, Inc.	MUH	Class II	2019-03-01
K190007	Vydence Laser Family	Vydence Medical Industria e Comercio Ltda	GEX	Class II	2019-03-01
K183705	IdentiTi Porous Ti Interbody System	Alphatec Spine, Inc.	MAX	Class II	2019-03-01
K183702	Polar Care Wave	Breg Inc	IRP	Class II	2019-03-01
K183690	Tenodesis Screw System	Paragon 28	MBI	Class II	2019-03-01
K183478	ClearON Mobile	Rayence Co., Ltd.	LLZ	Class II	2019-03-01
K183402	PRO-LITE Sterilization Tray	STERIS Corporation	KCT	Class II	2019-03-01
K183401	Vis-U-All Low Temperature Sterilization Pouch/Tubing	STERIS Corporation	FRG	Class II	2019-03-01
K183266	EP-TRACER System	Schwarzer Cardiotek GmbH	DQK	Class II	2019-03-01
K183259	Idys™ TLIF TiVac	Clariance-SAS	MAX	Class II	2019-03-01
K183147	BrackFix	Voco GmbH	DYH	Class II	2019-03-01
K183067	Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System	Taiwan Aulisa Medical Devices Technologies, Inc.	DQA	Class II	2019-03-01
K182822	Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System	Taiwan Aulisa Medical Devices Technologies, Inc.	DQA	Class II	2019-03-01
K182804	Traditional Length GJ Feeding Device	Applied Medical Technology Inc	KNT	Class II	2019-03-01
K182710	Fetal Doppler, Model FD88	Shenzzhen Luckcome Technology Inc., Ltd.	KNG	Class II	2019-03-01
K181932	DTX Studio design	Nobel Biocare AB	PNP	Class II	2019-03-01
K181871	EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay	Phadia AB	MVM	Class II	2019-03-01
K181788	Lead-free Chemical Indicators for Steam Sterilization	Kem Medical Products Corp.	JOJ	Class II	2019-03-01
K181730	BD Vacutainer Eclipse UltraFill Blood Collection Needle	Becton Dickinson & Co	FMI	Class II	2019-03-01
K181475	DxH 520 Hematology Instrument	Siemens Healthcare Diagnostics Inc.	GKZ	Class II	2019-03-01
K180852	Manual Wheelchair	Jiangyin Newrise Medical Equipment Co.,Ltd	IOR	Class I	2019-03-01
K180050	CurvaFix Intramedullary Rodscrew System	Curvafix, Inc.	HWC	Class II	2019-03-01
K173793	XactTrace Single Use Respiratory Effort Belt System	Embla Systems	MNR	Class II	2019-03-01
DEN180021	Early Bird Bleed Monitoring System	Saranas, Inc.	QFJ	Class II	2019-03-01
K183686	FUJIFILM Endoscope Model EG-530N	FUJIFILM Corporation	FDS	Class II	2019-02-28
K183313	EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)	Euroimmun US Inc.	MVM	Class II	2019-02-28
K183099	QUANTIEN Measurement System	St. Jude Medical (Now Abbott Medical)	DQK	Class II	2019-02-28
K182839	Lifetech Cardio Model 8301 Temporary Pacemaker	Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.	DTE	Class II	2019-02-28
K182629	Digital Thermometer	Joytech Healthcare Co., Ltd.	FLL	Class II	2019-02-28
K182250	Solero MTA Cart, Solero MTA System, Solero microwave Tissue Ablation Applicator (14cm), , Solero microwave Tissue Ablation Applicator (19cm), Solero microwave Tissue Ablation Applicator (29cm)	Boston Scientific Corporation	NEY	Class II	2019-02-28
K181528	Austin Miller Large External Fixation System	Austin Miller Trauma, LLC	KTT	Class II	2019-02-28
K180479	ReDS System	Sensible Medical Innovations Inc.	DSB	Class II	2019-02-28
K190155	FibermarX Radiopaque Tissue Marker	Viscus Biologics, LLC.	IYE	Class II	2019-02-27
K190087	EzDent-i / E2 / Prora View	Ewoosoft Co., Ltd	LLZ	Class II	2019-02-27
K183683	FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5	FUJIFILM Corporation	FDA	Class II	2019-02-27
K183014	uPMR 790	Shanghai United Imaging Healthcare Co., Ltd.	OUO	Class II	2019-02-27
K182494	FlowMet-R	Laser Associated Sciences, Inc.	DPW	Class II	2019-02-27
K182267	PAT (Pain Alleviation Technologies)	Marchan Medical, LLC	NUH	Class II	2019-02-27
K182003	Lympha Press Optimal Plus	MEGO AFEK AC Ltd.	JOW	Class II	2019-02-27
K180682	AeroPro Cordless Prophy System	Premier Dental Company Products	EKX	Class I	2019-02-27
K190356	ClariFix	Arrinex, Inc.	GEH	Class II	2019-02-26
K183454	Tyece OTC EMS System	Tyece, Ltd.	NGX	Class II	2019-02-26
K183374	GrayDuck Stent	Poll Medical LLC	IYE	Class II	2019-02-26
K183360	VITEK 2 AST-Gram Negative Meropenem/Vaborbactam (<=0.5/8 – >=64/8 µg/mL)	bioMerieux, Inc.	LON	Class II	2019-02-26
K183211	3M Comply Hydrogen Peroxide Chemical Indicator	3M Company	JOJ	Class II	2019-02-26
K182941	HEALIX ADVANCE SP PEEK Anchor	Medos International SARL	MBI	Class II	2019-02-26
K182440	Body System	A-1 Engineering	NGX	Class II	2019-02-26
K182052	Omni Instrument Tray	Hologic, Inc.	KCT	Class II	2019-02-26